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AzTrials

Metabolic SyndromeNCT01020617

The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome in Obese Children

A study testing Ls-33 in people with Metabolic Syndrome and Inflammation, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Metabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and it is likely that this is also the case in children (Ley et al., 2005). It has also been shown that the gut microbiota is different in obese individuals compared to normal weight individuals and that the microbiota seems to… Read more about this study

Who is it for?
Ages 12 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Metabolic Syndrome, Inflammation, Obesity
What is being tested?
Ls-33
How many people
51 participants
Where
1 siteDenmark
Study dates
Apr 2009to Jan 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 12-15 years
  • IsoBMI>30

Who cannot join

  • Chronical diseases
  • Chronical medication

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Copenhagen University

    Frederiksberg, 1958

Other trials in Denmark

About this study

Official title: Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being

Metabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and it is likely that this is also the case in children (Ley et al., 2005). It has also been shown that the gut microbiota is different in obese individuals compared to normal weight individuals and that the microbiota seems to have a role in fat storage (Backhead et al, 2004).

Intervention study with overweight and normal weight school age children. The children will be randomised to receive selected probiotics or a placebo. Fecal and blood samples will be collected, and anthropometric measurements (weight, height, skin folds) will be recorded before and after the intervention. The dynamic of the microbiota of the GI will be monitored by molecular methods. Markers of intestinal inflammation (calprotectin) and permeability will be analysed. Blood samples will be analysed to evaluate how the intervention influence the systemic polarization of the immune response by means of cytokine analyses. Furthermore, blood pressure, blood lipid profile and early markers of metabolic syndrome will be evaluated. Hypotheses This study will examine if overweight in children is associated with a different intestinal microbiota and if a change in microbiota caused by probiotics can modify inflammation and risk factors for the metabolic syndrome.

Being tested
Ls-33
Medical subject headings
Metabolic Syndrome, Inflammation, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ls-33Dietary supplement

    Also called L. salivarius Ls-33

    10~10 CFU/day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microbiota diversity

    Measured: one year

  2. Inflammation, CRP

    high sensitive C-reactive protein

    Measured: 2 months

Secondary outcomes (13)

  1. Antropometry

    Measured: one year

  2. Blood pressure

    Measured: one year

  3. Blood lipids

    Measured: one year

  4. Fasting insulin

    Measured: one year

  5. Fasting glucose

    Measured: one year

  6. C-reactive protein (CRP)

    Measured: 6 months

  7. Fecal calprotectin

    Measured: 7 months

  8. Interleukin-6 (Il-6)

    Measured: one year

  9. Interleukin-10 (IL-10)

    Measured: one year

  10. Tumor necrosis factor-alpha(TNF-α)

    Measured: one year

  11. Adiponectin

    Measured: one year

  12. Leptin

    Measured: one year

  13. GIP

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionAug 2010
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01020617
Sponsor's protocol ID
D206 ProTeen
Status last verified
Nov 2009
First submitted
16 Nov 2009
Last updated
19 Jan 2011
Results posted
No
Data monitoring committee
No

Publications

  • Larsen N, Vogensen FK, Gobel RJ, Michaelsen KF, Forssten SD, Lahtinen SJ, Jakobsen M. Effect of Lactobacillus salivarius Ls-33 on fecal microbiota in obese adolescents. Clin Nutr. 2013 Dec;32(6):935-40. doi: 10.1016/j.clnu.2013.02.007. Epub 2013 Mar 4.

    PubMed 23510724

  • Giacco R, Lappi J, Costabile G, Kolehmainen M, Schwab U, Landberg R, Uusitupa M, Poutanen K, Pacini G, Rivellese AA, Riccardi G, Mykkanen H. Effects of rye and whole wheat versus refined cereal foods on metabolic risk factors: a randomised controlled two-centre intervention study. Clin Nutr. 2013 Dec;32(6):941-9. doi: 10.1016/j.clnu.2013.01.016. Epub 2013 Feb 6.

    PubMed 23462537

  • Gobel RJ, Larsen N, Jakobsen M, Molgaard C, Michaelsen KF. Probiotics to adolescents with obesity: effects on inflammation and metabolic syndrome. J Pediatr Gastroenterol Nutr. 2012 Dec;55(6):673-8. doi: 10.1097/MPG.0b013e318263066c.

    PubMed 22695039

Questions about this trial

What is this clinical trial studying?

A study testing Ls-33 in people with Metabolic Syndrome and Inflammation, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiota diversity (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01020617, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2011.

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